Better Diagnostics for Life

Transcription

1 NASDAQ: NMRD Better Diagnostics for Life Interim Clinical Presentation sugarbeat 12 th September 2018

2 A Prospective Single Centre Evaluation of the Accuracy and safety of the sugarbeat Non-invasive Continuous Glucose Monitor (CGM) System: An interim Evaluation Dr T Rahman, MBBS, PhD Clinical research Manager, Nemaura Medical Inc., 2

3 Study Objective A EU based study to determine the safety and accuracy of the sugarbeat CGM to support FDA submission 3

4 Study Design Prospective single arm, single centre study Accuracy and safety assessed over 7 consecutive wear days, consisting of 3 non-consecutive in-clinic visits, and 4 home wear days. Venous blood samples used as reference for in-clinic portion of study using Architect c8000 Abbott Freestyle Optimum Neo BGM used as reference for Home Study Portion 4

5 Study Methods >25 subjects enrolled for screening at each of 3 stages 25 subjects selected after screening in each stage, with approximately equal split between Type 1 and Type 2 No subjects lost due to drop out All 25 subjects completed 2 days home study and 3 days inclinic study 12 subjects wore devices bilaterally during in-clinic phase 13 subjects had single device during in-clinic phase 25 subjects wore single device during home stage All subjects blinded to real-time glucose display All devices used single BGM calibrations per day in real-time 5

6 Baseline Characteristics Variable Age - Range years Age - Mean 52.8 years Age - Median 54.5 years Type 1 (n) 12 Type 2 (n) 13 6

7 Glucose range (mg/dl) Number of paired points ±10% or ±10 mg/dl : Mean Absolute Deviation MARD: Mean Absolute Relative Deviation Accuracy vs Glucose Range In-clinic portion of study 1-point calibration ±15% or ±15 mg/dl ±20% or ±20 mg/dl ±30% or ±30 mg/dl ±40% or ±40 mg/dl Outside ±40% or ±40 mg/dl % (MARD) (MARD) (MARD) (MARD) (MARD) (MARD) % % % % % Overall (4.59) (6.81) (8.77) (12.19) (14.99) 8.53 (17.31) NaN 0.00 NaN 0.00 NaN The performance evaluation included the proportion of the CGM system values that are within ±10 to >40% of relative difference of reference value at glucose levels >80 mg/dl and ± absolute difference at glucose level 80 mg/dl, ref: 7

8 Glucose range (mg/dl) Number of paired points ±10% or ±10 mg/dl Accuracy vs Glucose Range In-clinic portion of study 2-point Calibration ±15% or ±15 mg/dl ±20% or ±20 mg/dl ±30% or ±30 mg/dl ±40% or ±40 mg/dl The performance evaluation included the proportion of the CGM system values that are within ±10 to >40% of relative difference of reference value at glucose levels >80 mg/dl and ± absolute difference at glucose level 80 mg/dl, ref: Outside ±40% or ±40 mg/dl % (MARD) % (MARD) % (MARD) % (MARD) % (MARD) % (MARD) Overall (4.22) (6.21) (7.97) (10.65) (12.20) 3.97 (13.56) : Mean Absolute Deviation MARD: Mean Absolute Relative Deviation Note 1: Number of paired points is different/higher compared 1-point calibration in light of better accuracy leading to more data points falling within the mg/dL range Note 2: Total maximum number of paired points analysed = 4741, and not the sum of 1-point and 2- point calibration paired points, (as reported in error in Press release dated 12 th September 2018). 8

9 Interim Comparative MARD for In-Clinic phase as Primary Accuracy Metric Dexcom G5* sugarbeat no. of calibrations not known 1-point calibraiton 2-point calibraiton 1-point calibraiton 2-point calibraiton Overall MARD (20%/20mg/dL) 9.00 % Data Overall MARD (20%/20mg/dL) 8.77 % Data Overall MARD (20%/20mg/dL) 7.97 % Data Overall MARD (30%/30mg/dL) % Data Overall MARD (30%/30mg/dL) % Data * 9

10 Interim Comparative MARD for home-study phase as Primary Accuracy Metric Note 1: Senseonics, Dexcom G5 and sugarbeat = 2 point finger prick calibration * 10

11 Safety Evaluation Previous studies: >100 Patient days wear time No major adverse events or skin irritation reported. >525 Patient days wear time No major adverse events or skin irritation reported. Current study: >250 Patient days to date with no major adverse events or skin irritation reported. 11

12 Conclusion The interim analysis indicates the 3 day in-clinic portion of the study shows accuracy levels, as measured using overall nominal MARD, as comparable to previously reported data and within the targets for the intended indications. 12